MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVIGATION STEALTHSTATION TOOL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	961-581
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fighter was returned to the manufacturer for analysis.Analysis found that the fighter was returned attached to a clamp.The head of the attachment screw was slightly rounded out with tool marks all around the head of the screw.Despite the damage, the clamp was able to be removed.Otherwise, with markers was attached and fully seated, and the fighter returned a good geometry error.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.B5) for information regarding the first and second damaged instruments please refer to manufacturer report # 1723170-2018-04924 and #1723170-2018-04925.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding 4 damaged instruments.It was unknown if they could be verified or not.There was no patient present when this issue was found.
Additional Manufacturer Narrative
Correction: 510k/pma #.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NAVIGATION STEALTHSTATION TOOL
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7918324
• Report Number: 1723170-2018-04927
• Device Sequence Number: 11241349
• Product Code: OLO
• UDI-Device Identifier: 00721902467684
• UDI-Public: 00721902467684
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K983670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 961-581
• Device Catalogue Number: 961-581
• Device Lot Number: 140718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1